Coya Therapeutics, Inc. 8-K

What Happened
Coya Therapeutics, Inc. reported (8‑K filed Jan 8, 2026) positive results from an investigator‑initiated, open‑label proof‑of‑concept study in frontotemporal dementia (FTD). The 22‑week study enrolled 9 patients and tested subcutaneous CTLA4‑Ig combined with a 5‑day course of low‑dose IL‑2 given every four weeks. The study was led by Dr. Alireza Faridar and Dr. Stanley Appel at Houston Methodist Neurological Institute and funded by The Peggy and Gary Edwards Endowment Fund.

Key Details

• Study size and timeline: 9 patients; 22 weeks of dosing/follow‑up (22 weeks total).
• Safety: Most common adverse event was mild injection‑site erythema in 33.3% (3 of 9) of participants; no serious adverse events reported.
• Immune biomarkers: Regulatory T cell (Treg) suppressive function and Treg percentage were significantly increased as early as 2 weeks and remained elevated through week 22. CD25 and FOXP3 mean fluorescence intensity (MFI) were also significantly increased starting at 2 weeks and sustained through 22 weeks.
• Cognitive measures: MOCA scores essentially unchanged (baseline 13.5 vs week 22: 14); CDR‑FTLD did not change significantly (baseline 4.8 vs week 22: 5.5), indicating no measurable cognitive/functional decline over the 22‑week period.

Why It Matters
For investors, the filing documents early safety and biomarker activity for Coya‑relevant immune modulation in a small, investigator‑run FTD study. These results provide initial evidence of target engagement (Treg increases) and short‑term tolerability without serious adverse events. However, the data are from a small, open‑label proof‑of‑concept study and are preliminary; the filing does not include financial impacts or plans for regulatory or pivotal trials.